(57 days)
The Flexi-Stat SpO2 Sensor is indicated for continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring in patients weighing >20 kg.
The Flexi-Stat(tm) SpO2 Sensor is an electro-optical sensor that functions without skin penetration, electrical contact, or heat transfer. The sensor uses optical means to determine the light absorption of functional arterial hemoglobin by being connected between the patient and the oximeter. The sensor contains three optical components: two light emitting diodes (LED) that serve as light sources and one photodiode that acts as a light detector. The optical components are housed in a rigid, spring-loaded clip. The sensor cable is terminated in a DB-9 style connector, with an adapter cable for Datex-compatible models.
The provided document describes a 510(k) summary for the Flexi-Stat SpO2 Sensor, indicating its substantial equivalence to a predicate device for continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring. However, the document does not contain detailed information regarding acceptance criteria or a specific study that proves the device meets those criteria in a format that allows for the extraction of all the requested information.
Here's an analysis of what can and cannot be extracted from the provided text, based on your questions:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in detail. The document states "equivalent to predicate device accuracy claims" but does not provide specific numerical benchmarks for accuracy (e.g., A-rms values, bias, precision) or other performance metrics. | Not specified in detail. The document states "found to be equivalent to predicate device accuracy claims" and that "Design characteristics are equivalent in terms of safety and effectiveness, as demonstrated by product testing and accuracy claims." No specific performance metrics (e.g., SpO2 accuracy, pulse rate accuracy) are provided in numerical form. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not explicitly stated. The document mentions "clinical hypoxia studies" but does not provide the number of subjects or data points.
- Data Provenance:
- Country of Origin: Not specified. It mentions studies conducted "in an independent research lab," but the location of this lab is not given.
- Retrospective or Prospective: Not specified, but "clinical hypoxia studies" typically imply a prospective design where the device is tested on subjects under controlled conditions.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. The "ground truth" was established by "arterial blood samples analyzed on a laboratory co-oximeter," which implies laboratory personnel or medical professionals were involved in sample collection and analysis, but their qualifications are not detailed.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable/not specified. For an SpO2 sensor, the "ground truth" is typically a direct physiological measurement (co-oximetry) rather than an interpretation requiring adjudication among human experts.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- MRMC Comparative Effectiveness Study: No. This type of study is not relevant for an SpO2 sensor, which provides direct physiological measurements rather than aiding human readers in interpreting images or complex data. The device itself is a measurement tool, not an AI-assisted diagnostic aid for interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Yes, in terms of the device's measurement accuracy. The clinical hypoxia studies directly compared the Flexi-Stat's measurements to the co-oximeter’s results, indicating its performance as a standalone measurement device. There is no "human-in-the-loop" aspect to analyze beyond a clinician using the device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: Arterial blood samples analyzed on a laboratory co-oximeter. This is a direct physiological measurement and considered the gold standard for arterial oxygen saturation.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable/not specified. The device is a traditional electro-optical sensor, not an AI/ML algorithm that requires a "training set" in the machine learning sense. Its design and calibration would be based on engineering principles and physiological models, not data-driven training.
9. How the ground truth for the training set was established
- How Ground Truth for Training Set was Established: Not applicable. As mentioned, this is not an AI/ML device that uses a "training set" with established ground truth in the typical sense.
Summary of what the document implies about the study:
The document indicates that Elekon Industries, USA, Inc. conducted "clinical hypoxia studies in an independent research lab" where the Flexi-Stat SpO2 Sensor was "compared to arterial blood samples analyzed on a laboratory co-oximeter." The conclusion was that the device was "found to be equivalent to predicate device accuracy claims." This suggests a prospective, controlled clinical study designed to assess the accuracy of the SpO2 sensor against a gold standard (co-oximetry) under varying oxygen saturation levels induced by hypoxia. However, specific details such as the number of subjects, the range of SpO2 values tested, the statistical methods used, or the actual accuracy data (e.g., bias, precision, A-rms values) are not provided in this summary. The assessment focuses on demonstrating substantial equivalence to a predicate device, rather than detailing the full performance characteristics of the new device.
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NOV 2 6 2004
Appendix C Page 1 of 2
510(k) Summary
Submitter Information:
Elekon Industries, USA, Inc. 3848 Del Amo Blvd. Torrance CA 90503 USA
Contact:
Tom Dietiker, President Tel: 310-370-8022 Fax:310-861-5619
Date Prepared:
September 13, 2004
Product Name:
Common Name: SpO2 Sensor (accessory to pulse oximeter) Trade Name(s): Flexi-Stat SpO2 Sensors
Predicate Device:
The proposed devices are identical to the devices cleared under K041647 with the exception of added pediatric claims.
Description:
The Flexi-Stat(tm) SpO2 Sensor is an electro-optical sensor that functions without skin penetration, electrical contact, or heat transfer. The sensor uses optical means to determine the light absorption of functional arterial hemoglobin by being connected between the patient and the oximeter. The sensor contains three optical components: two light emitting diodes (LED) that serve as light sources and one photodiode that acts as a light detector. The optical components are housed in a rigid, spring-loaded clip. The sensor cable is terminated in a DB-9 style connector, with an adapter cable for Datex-compatible models.
Intended Use:
The Flexi-Stat SpO2 Sensor is indicated for continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring.
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Comparison to Predicate Device:
The Flexi-Stat SpO2 Sensor uses the same theory and principle of operation as the predicate device. Design characteristics are equivalent in terms of safety and effectiveness, as demonstrated by product testing and accuracy claims.
Performance Data & Conclusions:
Performance testing was conducted during clinical hypoxia studies conducted in an independent research lab. The Flexi-Stat was compared to arterial blood samples analyzed on a laboratory co-oximeter and found to be equivalent to predicate device accuracy claims.
Biocompatibility, electrical safety, and EMC testing was also performed to demonstrate conformance with established industry standards.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of an eagle with three stripes representing the department's mission to protect the health of all Americans and provide essential human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 26 2004
Elekon Industries USA, Incorporated C/O Ms. Krista Oakes Amica Solutions 2300 McDermott Road, #200-207 Plano, Texas 75025
Re: K042704
Trade/Device Name: Flexi-Stat™ Reusable Finger Clip Sp02 Sensors Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: September 29, 2004 Received: October 4, 2004
Dear Ms. Oakes:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting vour device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition. FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Ms. Oakes
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours.
Clas
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) # (if known):
Device Name: Flexi-Stat™ Reusable Finger Clip SpO2 Sensors
Indications for Use:
The Flexi-Stat SpO2 Sensor is indicated for continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring in patients weighing >20 kg.
Prescription Use _ x (21 CFR 801 Subpart D) AND/OR
Over-the-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Cees Soglione
(Division Sign-Off) (Division of Anesthesiology, General Hospital, Infection Control, Dental Devic
510(k) Number:
§ 870.2700 Oximeter.
(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).